NCT06062940

Brief Summary

The SHARE Approach Evaluation study was meant to evaluate the SHARE Approach, designed by AHRQ and updated by UCD. The SHARE Approach is a training program for clinicians on shared decision making.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 2, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

3.7 years

First QC Date

September 7, 2023

Last Update Submit

August 8, 2024

Conditions

Outcome Measures

Primary Outcomes (8)

  • Clinician training evaluation: Confidence in ability to do shared decision making

    Clinician confidence in doing shared decision making was measured by a brief card survey question with a 5 point Likert scale. Possible scores range from 1 to 5, with lower scores indicating less usefulness and higher scores indicating more usefulness.

    pre-training, post-training, 2-month follow-up

  • Clinician training evaluation: Confidence in understanding what shared decision making is

    Clinician confidence in understanding shared decision making was measured by a brief card survey question with a 5 point Likert scale. Possible scores range from 1 to 5, with lower scores indicating less usefulness and higher scores indicating more usefulness.

    pre-training, post-training

  • Card survey: Clinician satisfaction with encounter

    Clinician satisfaction with encounter was measured by a brief card survey question with a 5 point Likert scale. Possible scores range from 1 to 5, with lower scores indicating less usefulness and higher scores indicating more usefulness.

    pre-training, 1 month post-training, 6 month follow-up

  • Card survey: Patient satisfaction with encounter

    Patient satisfaction with encounter was measured by a brief card survey question with a 5 point Likert scale. Possible scores range from 1 to 5, with lower scores indicating less usefulness and higher scores indicating more usefulness.

    pre-training, 1 month post-training, 6 month follow-up

  • Card survey: Clinician shared decision making (self-reported)

    After clinician/patient encounters, clinicians were asked to fill out a brief card survey rating shared decision making that occurred during the encounter. These include questions from the Dyadic OPTION (observing patient involvement in decision making) scale. Higher scores reflected better experiences of shared decision making, whereas lower scores reflected poorer experiences of shared decision making.

    pre-training, 1 month post-training, 6 month follow-up

  • Card survey: Patient shared decision making (self-reported)

    After clinician/patient encounters, patients were asked to fill out a brief card survey rating their experiences with shared decision making during the encounter. These included questions modified from the Dyadic OPTION (observing patient involvement in decision making) scale. Higher scores reflected better experiences of shared decision making, whereas lower scores reflected poorer experiences of shared decision making.

    pre-training, 1 month post-training, 6 month follow-up

  • Audio recordings: Shared Decision Making (highest score of topics discussed)

    A subset of clinician/patient encounters were audio recorded, and then coded using a modified OPTION (observing patient involvement in decision making) 12 coding schema for elements of shared decision making occurring within the encounter. As a primary outcome, we selected the highest-scored topic discussed in each encounter. Higher scores reflected better experiences of shared decision making, whereas lower scores reflected poorer experiences of shared decision making.

    pre-training, 1 month post-training, 6 month follow-up

  • Clinician training evaluation: Overall evaluation of the SHARE training

    clinicians answered the question: Overall, what was your experience of the training you received today. Likert rating scale was "Very positive" to "Very negative"

    post-training

Secondary Outcomes (1)

  • Shared Decision Making (total score)

    pre-training, 1 month post-training, 6 month follow-up

Study Arms (2)

Primary Care Practice

We recruited 10 primary care practices from across Colorado, from all regions of the state (e.g., Eastern Plains, Mountain West, Front Range), and a mix of rural and urban practices of varying sizes. We recruited both practice staff and patients for this cohort.

Behavioral: SHARE Approach

Cardiology Practice

We recruited 2 cardiology practices from across Colorado, from all regions of the state (e.g., Eastern Plains, Mountain West, Front Range), and a mix of rural and urban practices of varying sizes. We recruited both practice staff and patients for this cohort.

Behavioral: SHARE Approach

Interventions

SHARE ApproachBEHAVIORAL

The SHARE Approach training was given at each of these centers, teaching skills to clinicians about shared decision making.

Cardiology PracticePrimary Care Practice

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Population to be enrolled include clinicians and any practice staff who participate in the SHARE Approach training in 12 practices to be recruited across Colorado. Patients will also be enrolled for the card surveys and audio recordings if they are meeting with a clinician who has taken the SHARE Approach training.

You may qualify if:

  • Population to be enrolled include clinicians and any practice staff who participate in the SHARE Approach training in 12 practices to be recruited across Colorado.
  • Patients will also be enrolled for the card surveys and audio recordings if they are meeting with a clinician who has taken the SHARE Approach training.
  • to 89 years old

You may not qualify if:

  • Children
  • Decisionally challenged
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Study Officials

  • Laura Scherer, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2023

First Posted

October 2, 2023

Study Start

August 1, 2019

Primary Completion

March 30, 2023

Study Completion

November 30, 2023

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations